本文關(guān)鍵詞：酶法測(cè)定游離脂肪酸的評(píng)價(jià)與研究　出處：《北京理工大學(xué)》2015年碩士論文　論文類型：學(xué)位論文

  更多相關(guān)文章： 酶法 游離脂肪酸 檢測(cè)試劑盒 性能評(píng)估 臨床應(yīng)用

【摘要】：研究意義和目的由于血中游離脂肪酸FFA在糖尿病(diabetes mellitus,DM)、心血管病(angiocardiopathy,CD)等疾病的發(fā)病機(jī)理及作用方面的重要意義,對(duì)人體血清中游離脂肪酸含量進(jìn)行檢測(cè),能夠盡早發(fā)現(xiàn)患者血清中游離脂肪酸的異常情況,最終起到預(yù)防及盡早對(duì)相關(guān)疾病進(jìn)行治療的目的。因此,FFA檢測(cè)對(duì)于糖尿病的診斷、預(yù)后跟蹤控制、機(jī)理研究等方面具有重要的意義。盡管已有多種FFA檢測(cè)試劑盒上市,尚缺乏對(duì)各種檢測(cè)方法和不同試劑間的系統(tǒng)的方法學(xué)和診斷效能的評(píng)價(jià),測(cè)定方法尚未統(tǒng)一,因此亟需對(duì)現(xiàn)有檢測(cè)方法的快速和準(zhǔn)確特性進(jìn)行研究和評(píng)價(jià),這將有利于臨床工作的開展。本論文對(duì)市場(chǎng)上國(guó)產(chǎn)和進(jìn)口的游離脂肪酸測(cè)定試劑盒(酶法)用于臨床診斷檢測(cè)性能的等效性,以及在Ⅱ型糖尿病和心血管病上的臨床應(yīng)用價(jià)值展開評(píng)價(jià)。方法選擇醫(yī)院檢驗(yàn)科健康查體人員及糖尿病患者、心血管疾病、甲機(jī)能亢進(jìn)、肢端肥大癥、嚴(yán)重肝病和饑餓、甲狀腺機(jī)能減退、腦垂體功能不全、阿狄森氏病等病癥的血清,入選樣本100例。根據(jù)NCCLS相關(guān)的EP標(biāo)準(zhǔn),對(duì)北京九強(qiáng)生物技術(shù)股份有限公司、英國(guó)朗道公司和德國(guó)德賽公司的游離脂肪酸檢測(cè)試劑盒進(jìn)行檢測(cè)限、線性、精密度、抗干擾能力來評(píng)價(jià)試劑盒的臨床檢測(cè)性能,并對(duì)九強(qiáng)、朗道、德賽三家公司的游離脂肪酸檢測(cè)試劑盒進(jìn)行相關(guān)性評(píng)價(jià),評(píng)價(jià)兩兩間的相關(guān)性。本研究進(jìn)一步選擇Ⅱ型糖尿病和心血管疾病臨床樣本和健康對(duì)照樣本共200例,對(duì)血清中游離脂肪酸在自動(dòng)生化分析儀上檢測(cè)。分析正常對(duì)照組與病例組是否存在顯著差異。統(tǒng)計(jì)學(xué)分析應(yīng)用SPSS17.0軟件進(jìn)行,計(jì)量資料以x±S表示,以P0.05為差異具有統(tǒng)計(jì)學(xué)意義。結(jié)果相關(guān)性分析顯示,三種試劑盒兩兩之間均具有良好的相關(guān)性,R2均大于0.99,產(chǎn)品測(cè)試結(jié)果在統(tǒng)計(jì)學(xué)上無差異,一致性很好。精密度結(jié)果顯示,九強(qiáng)試劑批內(nèi)CV為0.44%~1.29%,系統(tǒng)CV為0.85%~1.89%,朗道試劑批內(nèi)CV為0.50%~1.52%,系統(tǒng)CV為0.84%~2.18%,德賽試劑批內(nèi)CV為0.40%~1.23%,系統(tǒng)CV為0.92%~2.51%。干擾試驗(yàn)結(jié)果顯示德賽試劑對(duì)TG高于600mg/dl濃度的樣本有影響,九強(qiáng)和朗道試劑對(duì)TG高于900 mg/dl濃度的樣本有影響。德賽試劑盒對(duì)VC基本沒有抗干擾能力,九強(qiáng)和朗道試劑盒對(duì)VC 50mg/dl濃度的樣本沒有影響。朗道試劑盒對(duì)DB的抗干擾能力很差,九強(qiáng)和德賽試劑盒對(duì)DB 40mg/dl濃度的樣本沒有影響。九強(qiáng)、德賽、朗道試劑盒對(duì)HB 300mg/dl濃度的樣本沒有影響。線性試驗(yàn)結(jié)果顯示,三種試劑盒線性相關(guān)性良好,且差異均無統(tǒng)計(jì)學(xué)意義(P0.05)。檢測(cè)限結(jié)果顯示,九強(qiáng)、朗道、德賽三家試劑盒的空白檢測(cè)限分別為:0.0301 mmol/L、0.0340 mmol/L、0.0484 mmol/L,檢測(cè)低限分別為0.0622mmol/L、0.0836mmol/L、0.1133mmol/L,功能靈敏度分別為0.0996mmol/L、0.1037mmol/L、0.1259mmol/L。Ⅱ型糖尿病研究結(jié)果表明,正常對(duì)照組血清FFA檢測(cè)結(jié)果為0.56±0.19mmol/L,病例組血清FFA檢測(cè)結(jié)果為0.99±0.49 mmol/L,通過對(duì)病例組及對(duì)照組檢測(cè)結(jié)果分析,Ⅱ型糖尿病患者血清FFA濃度與對(duì)照組血清FFA濃度有顯著性差異,前者高于后者。心血管病研究結(jié)果表明,正常對(duì)照組血清FFA檢測(cè)結(jié)果為0.56±0.13mmol/L,冠心病組血清FFA檢測(cè)結(jié)果為1.06±0.22mmol/L,高血脂組血清FFA檢測(cè)結(jié)果為0.68±0.31mmol/L,高血壓組血清FFA檢測(cè)結(jié)果為0.90±0.26mmol/L,通過對(duì)病例組及對(duì)照組檢測(cè)結(jié)果分析,冠心病患者和高血壓患者血清FFA濃度與對(duì)照組血清FFA濃度有顯著性差異,冠心病患者和高血壓患者高于正常對(duì)照組。高血脂組與正常對(duì)照組相比FFA無顯著差異,結(jié)果相差不大。結(jié)論1、九強(qiáng)、朗道以及德賽三家公司FFA試劑盒具有良好的相關(guān)性。2、九強(qiáng)的試劑抗干擾能力和檢測(cè)限優(yōu)于朗道和德賽試劑,線性和精密度與朗道和德賽試劑基本無差異,三家試劑比較具體有等效性且臨床符合性良好。3、九強(qiáng)公司生產(chǎn)的FFA檢測(cè)試劑盒的臨床檢測(cè)性能良好,在臨床上具有推廣應(yīng)用的潛在價(jià)值。4、通過對(duì)血清FFA在糖尿病和心血管疾病中的作用進(jìn)行探討,可以看出,臨床上通過對(duì)血清FFA的監(jiān)測(cè),可以預(yù)測(cè)Ⅱ型糖尿病的發(fā)展和控制情況。血清FFA水平升高是冠心病和高血壓發(fā)生的特征之一。
[Abstract]:Study on the significance and purpose of the blood free fatty acid FFA in diabetes (diabetes mellitus, DM), cardiovascular disease (angiocardiopathy, CD) important role in pathogenesis and disease, to detect the content of free fatty acid in human serum, can as early as possible abnormal free fatty acid in serum. Finally to the prevention and treatment of related diseases as soon as possible. Therefore, FFA detection for the diagnosis of diabetes, the prognosis of tracking control, has important significance in researching the mechanism. Although there are a variety of FFA detection kit market, lack of all kinds of methods of detection method and system between different agents and diagnostic efficiency the evaluation and determination method is not unified, so the research and evaluation of the urgent need for the existing detection methods of fast and accurate characteristics, which will be conducive to clinical work. In this paper The market of domestic and imported free fatty acid determination kit (enzymatic) for equivalent performance of clinical diagnostic tests, as well as in type II diabetes and cardiovascular disease on the clinical value of the evaluation methods. The hospital health examination personnel and patients with diabetes, cardiovascular disease, thyroid hyperfunction, acromegaly, serious liver disease and hunger, hypothyroidism, pituitary dysfunction, serum Addison's disease and other diseases, 100 cases of selected samples. According to the NCCLS EP standard, the Beijing nine strong biotechnology Limited by Share Ltd, the Landau company and the German company DESAY free fatty acid detection kit for detection limit, linearity, precision the performance and anti-interference ability to evaluate the clinical detection kit, and on the nine, Landau, the DESAY company's three free fatty acid detection kit for correlation evaluation, evaluation The correlation between the 22. This study further selection of type II diabetes and cardiovascular disease in clinical samples and samples of healthy control were 200 cases of detection in the automatic biochemical analyzer of free fatty acid in serum. Analysis of normal control group and the case group had significant difference. Statistical analysis was conducted using SPSS17.0 software, measurement data with x + S P0.05 said, the difference was statistically significant. The results of correlation analysis showed that between the three kit 22 has good correlation, R2 was greater than 0.99, product testing results in no statistically difference, good consistency. The precision of the results showed that the nine strong group of CV reagent for 0.44%~1.29%, CV for 0.85%~1.89% system Landau, the inside of CV 0.50%~1.52% reagent, 0.84%~2.18% reagent system CV, DESAY inside group CV 0.40%~1.23%, system CV 0.92%~2.51%. interference test showed that DESAY reagent on TG than Effect of concentration of 600mg/dl samples, nine strong influence and Landau reagent is higher than 900 mg/dl concentration of TG samples. The DESAY kit of VC basically no anti-interference ability, no effect nine and Landau kit of VC 50mg/dl concentration in the sample. The anti-interference ability of Landau kit of DB is very poor, no effect nine strong and DESAY kit of DB 40mg/dl concentration in the sample. Nine, DESAY did not affect Landau kit on HB 300mg/dl concentration samples. The results of linear test showed that three kinds of correlation kit with good linearity, and the differences were not statistically significant (P0.05). The results show that the detection limit, nine, Landau, blank test three DESAY home kit limit were 0.0301 mmol/L, 0.0340 mmol/L, 0.0484 mmol/L, lower limit of detection were 0.0622mmol/L, 0.0836mmol/L, 0.1133mmol/L, functional sensitivity were 0.0996mmol/L, 0.1037mmol/L, 0.1259mmol/L. II Diabetes research results show that the normal control group serum FFA detection results of 0.56 + 0.19mmol/L, case group serum FFA detection results of 0.99 + 0.49 mmol/L, according to the case group and the control group analysis, there was significant difference in type II diabetic serum FFA concentration and serum FFA concentration in control group, the former was higher than the latter cardiovascular disease. The results show that the normal control group serum FFA detection results of 0.56 + 0.13mmol/L, FFA serum test results for 1.06 + 0.22mmol/L, high cholesterol serum FFA detection results of 0.68 + 0.31mmol/L, hypertension group serum FFA detection results of 0.90 + 0.26mmol/L, the case group and the control group test results analysis, there was significant the difference in patients with coronary heart disease and serum FFA concentration in patients with hypertension and control group serum FFA concentration in patients with coronary heart disease in patients with hypertension, and higher than the normal control group hyperlipidemia group and the positive. Often compared to the control group FFA had no significant difference, the results are not significant. Conclusion: 1, nine, Landau and DESAY three companies FFA kit has a good correlation to.2, reagent nine strong anti-interference ability and the detection limit is better than DESAY and Landau reagent, linearity and precision and the reagent had no difference between Landau and DESAY, three an equivalent and more specific reagent have good agreement with the clinical performance of.3 clinical detection kit FFA kit nine strong company production is good,.4 has a potential value in clinical application, this paper discusses the role of FFA in the serum, diabetes and cardiovascular disease can be seen by clinical monitoring of serum FFA, can predict and control the development of type II diabetes. Elevated serum FFA level is one of the characteristics of coronary heart disease and hypertension.

【學(xué)位授予單位】：北京理工大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2015
【分類號(hào)】：R446.112

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相關(guān)期刊論文 前1條

1 李靜;邵亮;;2型糖尿病與血清游離脂肪酸水平的關(guān)系[J];實(shí)用臨床醫(yī)學(xué);2011年02期

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本文編號(hào)：1378169